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Safety Reports: Medical Devices

Updated:

Recent Reports

Insulet Corporation Omnipod DASH Personal Diabetes Managers - recalled due to battery issue, USA

1 year ago •source fda.gov • details

Recall notice

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Insulet received reports from Omnipod… See more

#recall #medicaldevices #us

Insulet Corporation Omnipod DASH Personal Diabetes Managers - recalled due to battery issue photo #1
321

Gibeck® and Iso-Gard® Bacterial and viral filters - recalled due to Bacterial and viral filters, USA

1 year ago •source fda.gov • details

Recall notice

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment… See more

#recall #medicaldevices #us

321

Mighty Bliss Electric Heating Pad - recalled due to product safety concerns, USA

1 year ago •source fda.gov • details

Recall notice

Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation. Product was sold via Amazon.com and Walmart.com. We received 286 complaints between July 2021 to September… See more

#recall #amazon #walmart #medicaldevices #us #sub #ro-tel

Mighty Bliss Electric Heating Pad - recalled due to product safety concerns photo #1
321

WatchCare Incontinence management system - Urgent Medical Device Correction due to potential RF interference with other medical devices, USA

1 year ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare System is distributed in the United States.

This Urgent Medical Device Correction applies to… See more

#blood #medicaldevices #us #feta #ro-tel

WatchCare Incontinence management system - Urgent Medical Device Correction due to potential RF interference with other medical devices photo #1
321

Family Dollar OTC medical products - recalled due to storage outside of labeled temperature, USA

2 years ago •source fda.gov • details

Recall notice

Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside… See more

#familydollar #medicaldevices #us #cream #sub #ham #ro-tel

Family Dollar OTC medical products - recalled due to storage outside of labeled temperature photo #1
322

Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury, USA

2 years ago •source fda.gov • details

Recall notice

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting… See more

#blood #recall #medicaldevices #us #sub #hunts

Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury photo #1
321

Intraosseous Products - recalled due to limited or non-functioning intraosseous access, USA

2 years ago •source fda.gov • details

Recall notice

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers. Certain lots within the expiration date of these intraosseous products may result in the following:… See more

#medicaldevices #us

321

Volara System (home care) - recalled due to possible risk of oxygen desaturation, USA

2 years ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion… See more

#medicaldevices #us

321

Philips Respironics V60/V60 Plus, and V680 - recalled due to potential power supply issue, USA

2 years ago •source fda.gov • details

Recall notice

Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics… See more

#recall #medicaldevices #us #sub #ro-tel

321

Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and rodent contamination, USA

2 years ago •source fda.gov • details

Recall notice

Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the… See more

#mice #rats #rodents #medicaldevices #drugs #recall #dogfood #petfood #catfood #familydollar #us #salmonella #applegate #wesson #arnold

Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and rodent contamination photo #1
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